Anxiety & Depression Association of America

Virtual Reality (VR) for Interventional Radiology (IR) Procedures

Purpose

The goal of this clinical trial is to to utilize Virtual Reality during their interventional radiology procedure to help reduce any pain and anxiety experienced during the procedure in patients above the age of 8 undergoing interventional radiology procedures. The main questions it aims to answer are: - To determine if Virtual Reality is more effective than standard care for reducing pain and anxiety in children undergoing painful interventional radiology procedures. It is hypothesized that children in the Virtual Reality condition will experience reduced pain and anxiety compared to children receiving standard of care. - To evaluate caregiver's assessment of patient distress and their satisfaction with Virtual Reality compared to standard of care. It is hypothesized that caregiver satisfaction with the medical procedure will be significantly greater in the Virtual Reality group compared to the standard of care group. It is hypothesized that caregivers will perceive lower pain/anxiety when their child receives Virtual Reality compared to standard of care. Participants will complete pre and post surveys before and after interventional radiology procedures. Participants will use Virtual Reality headsets while undergoing procedure.

Conditions

Pain
Procedural Anxiety

Eligibility

Eligible Ages: Over 8 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Children who are at least 8 years old - Children who are English speaking with caregivers who are English speaking or Spanish speaking. - Children who are undergoing an interventional radiology procedure are eligible to participate in this project. - Only children who are in the normal range of development will be recruited for this study. This will be assessed by report from the parents. The rationale for excluding patients with developmental delay is that due to their cognitive impairments, such children react to the stressors of surgery differently than do children without such developmental delay. It is unclear how such children would use the interventions included in this study, and it is likely that their responses on baseline and outcome measures will differ from children of normal developmental parameters.

Exclusion Criteria

Children who are currently taking pain medication or anxiolytic medication will be excluded from this study. - Children with a psychiatric disorder, organic brain syndrome, intellectual disability, or other known cognitive/neurological disorders - Children with visual, auditory, or tactile deficits that would interfere with the ability to complete the experimental tasks - Children with a history of seizure disorder. - Children currently sick with flu-like symptoms or experiencing a headache or earache. - Children with known or suspected motion sickness. - Children with cochlear implants or pacemakers.

Study Design

Phase
Study Type: Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional

Arm Groups

Arm	Description	Assigned Intervention
Use of Virtual Reality	Five minutes before the procedure and wear it throughout the procedure and can keep it on up to two minutes after procedure.	Device: Meta Oculus Quest Pro Participants 10 and older can use the Meta Oculus Quest Pro headset. The headset contains content that is appropriate for patients of 10 and older with no developmental delays. The visual a bright, vibrant color and a quality image. The Virtual reality game is equipped enables the player to look around the virtual environment. In addition, there is the option to interact with the Virtual reality environment using a handheld remote. Therefore, the child will be receiving distraction via 3-D visual and auditory sensory, and tactile feedback, thus supplying a multi-sensory immersive experience. While wearing these glasses, the children only can see the Head-Mounted Display screen so that the immersion and presence will be increased. The Virtual reality glasses will be sanitized before every use so that the chance of infection will be minimized. Device: Pico 4 Participants 8-18 can use the Pico 4 headset. The headset contains content that is appropriate for patients aged 8-18 with no developmental delays. The visual a bright, vibrant color and a quality image. The Virtual reality game is equipped enables the player to look around the virtual environment. In addition, there is the option to interact with the Virtual reality environment using a handheld remote. Therefore, the child will be receiving distraction via 3-D visual and auditory sensory, and tactile feedback, thus supplying a multi-sensory immersive experience. While wearing these glasses, the children only can see the Head-Mounted Display screen so that the immersion and presence will be increased. The Virtual reality glasses will be sanitized before every use so that the chance of infection will be minimized. Device: Pico G3 Participants 13 and older can use the Pico G3 headset. The headset contains content that is appropriate for patients of 13 and older with no developmental delays. The visual a bright, vibrant color and a quality image. The Virtual reality game is equipped enables the player to look around the virtual environment. In addition, there is the option to interact with the Virtual reality environment using a handheld remote. Therefore, the child will be receiving distraction via 3-D visual and auditory sensory, and tactile feedback, thus supplying a multi-sensory immersive experience. While wearing these glasses, the children only can see the Head-Mounted Display screen so that the immersion and presence will be increased. The Virtual reality glasses will be sanitized before every use so that the chance of infection will be minimized.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Children's Hospital Los Angeles

Study Contact

Saloni M Dangoria
(323) 361-4342
sdangoria@chla.usc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.